Taking the handoffs out of
nonclinical evaluation

A device developer preparing a nonclinical safety package usually ends up coordinating four workstreams at once — biocompatibility, safety evaluation, durability testing and CMC documentation — often across separate vendors. Every handoff costs something: samples get re-prepared, the product gets re-explained, and data arrives in formats that have to be reconciled before it can go into a submission.

These workstreams are run as one programme rather than four engagements. Organ-chip prescreening sits ahead of the animal phase; the GLP studies themselves are carried out at the Yangtze River Delta National Innovation Centre for Drug Safety Evaluation Technology, which sits within the same national innovation system as the platform; submission coordination is handled on the same programme.

At scoping we confirm the device classification, the applicable test battery, and whether the required tests fall within the evaluation centre's accredited scope. If any part of your programme falls outside it, we will say so at that point rather than after contracting.